W.L. Gore & Associates, Inc. - 148 FDA 510(k) Cleared Devices (Latest 2025)

GORE? Tri-Lobe Balloon Catheter

K250410 · DQY Catheter, Percutaneous · Cardiovascular

Jun 2025 109d

GORE? PROPATEN? Vascular Graft

K240083 · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · Cardiovascular

Mar 2024 50d

GORE? PROPATEN? Vascular Graft

K232312 · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · Cardiovascular

Jan 2024 160d

GORE? ACUSEAL Vascular Graft

K233551 · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · Cardiovascular

Dec 2023 46d

GORE? ACUSEAL Vascular Graft

K231505 · DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · Cardiovascular

Jun 2023 30d

GORE BIO-A Tissue Reinforcement

K191773 · OWT Mesh, Surgical, Absorbable, Abdominal Hernia · General & Plastic Surgery

Jul 2019 29d

GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement

K181940 · OXC Mesh, Surgical, Absorbable, Staple Line Reinforcement · General & Plastic Surgery

Aug 2018 29d

GORE ENFORM Biomaterial

K173333 · OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery · General & Plastic Surgery

Apr 2018 164d

GORE SYNECOR Preperitoneal Biomaterial

K163576 · FTL Mesh, Surgical, Polymeric · General & Plastic Surgery

May 2017 143d

GORE VIABIL Short Wire Biliary Endoprosthesis

K170740 · FGE Stents, Drains And Dilators For The Biliary Ducts · Gastroenterology & Urology

May 2017 59d

GORE BIO-A Tissue Reinforcement

K163217 · OXF Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery · General & Plastic Surgery

Feb 2017 86d

GORE DrySeal Flex Introducer Sheath

K160254 · DYB Introducer, Catheter · Cardiovascular

May 2016 101d